HealthyPhase 1NCT05809271
Acute Effects of 3,4-methylenedioxymethamphetamine (MDMA) With and Without a Booster Dose
A Phase 1 study testing MDMA 120 mg + MDMA 60 mg in people with Healthy, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
3,4-methylenedioxymethamphetamine (MDMA) is a psychoactive substance and prototypical empathogen acutely inducing feelings of heightened mood, empathy, trust and closeness to others. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MDMA 120 mg + MDMA 60 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Nov 2023to 7 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Good understanding of the German language.
- Understanding the procedures and the risks that are associated with the study.
- Participants must be willing to adhere to the protocol and sign the consent form.
- Participants must be willing to refrain from taking illicit psychoactive substances during the study.
- Participants must be willing to drink only alcohol-free liquids and no coffee, black or green tea, or energy drinks after midnight of the evening before the study session, as well as during the study day.
- Participants must be willing not to drive a traffic vehicle or to operate machines within 48h after substance administration.
- Willing to use effective birth control throughout study participation.
- Body mass index between 18-29 kg/m2.
Who cannot join
- Relevant chronic or acute medical condition.
- Current or previous major psychiatric disorder.
- Psychotic disorder in first-degree relatives, not including psychotic disorders secondary to an apparent medical reason, e.g. brain injury, dementia, or lesions of the brain.
- Hypertension (SBP>140/90 mmHg) or hypotension (SBP<85 mmHg).
- Previous MDMA use more than 20 times or any time within the previous month.
- Pregnant or nursing women.
Show all 10Show fewer
- Participation in another clinical trial (currently or within the last 30 days).
- Use of medications that may interfere with the effects of the study medications.
- Tobacco smoking (>10 cigarettes/day).
- Consumption of alcoholic drinks (>15 drinks/week).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of 3,4-methylenedioxymethamphetamine (MDMA) With and Without a Booster Dose (MDMA-booster Study)
3,4-methylenedioxymethamphetamine (MDMA) is a psychoactive substance and prototypical empathogen acutely inducing feelings of heightened mood, empathy, trust and closeness to others. The current study investigates differences in duration of acute effects and side effects after administration of a single dose of MDMA compared to a repeated administration.
Read the detailed description
MDMA is a psychoactive substance that primarily enhances serotonergic neurotransmission by releasing 5-HT through the SERT. It also releases dopamine and norepinephrine, although less potently, through the dopamine transporter and norepinephrine transporter, respectively. In addition to its use as a recreational drug, MDMA-assisted psychotherapy has been investigated in several phase 2 trials and one phase 3 trial for PTSD. Further indications for MDMA-assisted therapy being planned or ongoing are eating disorders, social anxiety, and alcohol use disorder.
The present study focuses on dosing aspects of MDMA used in clinical studies and recreational settings, specifically the benefits of a second administration (booster dose) given several hours after the initial dose. Most published studies of MDMA-assisted psychotherapy used a booster dose. A typical dosing regimen would be 80-120 mg of MDMA initially followed by half the initial dose after 1.5-2.5 hours. Although previous studies have found that a booster dose could prolong the acute effects of MDMA, others have shown an acute tolerance reflected in the finding that acute subjective effects return to baseline within 4-5 hours, while plasma concentrations are still close to peak levels.
These findings have led to controversy regarding how effective a booster dose would be in prolonging acute effects, as it has never been directly compared to placebo. Additionally, the higher total dose could lead to an increase in side effects.
Therefore, the present phase 1 study intends to compare the acute subjective, physiological, and endocrine effects of MDMA (120 mg + 60 mg after 2 hours), MDMA (120 mg + placebo after 2 hours), and (placebo + placebo after 2 hours) using a double-blind, random-order, crossover design in healthy subjects.
- Conditions
- Healthy
- Being tested
- MDMA 120 mg + MDMA 60 mg, MDMA 120 mg + placebo, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDMA 120 mg + MDMA 60 mgDrug
Also called 3,4-Methylenedioxymethamphetamine
An oral dose of 120 mg racemic MDMA will be administered followed by a second dose of 60 mg racemic MDMA two hours later.
MDMA 120 mg + placeboDrug
Also called 3,4-Methylenedioxymethamphetamine
An oral dose of 120 mg racemic MDMA will be administered followed by a placebo two hours later.
PlaceboDrug
An oral placebo will be administered followed by a placebo two hours later.
| Study group | Role | What they receive |
|---|---|---|
| MDMA with booster | Experimental | MDMA followed by MDMA Receives: Drug: MDMA 120 mg + MDMA 60 mg |
| MDMA without booster | Experimental | MDMA followed by placebo Receives: Drug: MDMA 120 mg + placebo |
| Placebo | Placebo comparator | Placebo followed by placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective effect duration for "any drug effect"
Assessed by visual analog scale (VAS) using 10% of the individual maximal subjective response (Emax) as threshold for the onset and offset.
Measured: Every 15 minutes for 9 hours after substance administration
Secondary outcomes (24)
Maximal subjective effects for "any drug effect"
Maximal subjective response (Emax), of "any drug effect" assessed by visual analog scale (VAS).
Measured: Every 15 minutes for 9 hours after substance administration
Total subjective effects for "any drug effect"
Area under the effect curve (AUEC) of "any drug effect" assessed by visual analog scale (VAS).
Measured: Every 15 minutes for 9 hours after substance administration
Further acute subjective effects I duration
Effect duration for "good drug effect", "bad drug effect", "liking", "stimulated", "high", "anxiety", "I am emotional", "talkative", "happy", "open", "trust", "feeling close to others", "want to be alone", and "want to be with others", assessed by visual analog scale (VAS) using 10% of the individual maximal subjective response (Emax) as threshold for the onset and offset.
Measured: Every 30 minutes for 9 hours after substance administration
Further acute subjective effects II maximal effects
Maximal subjective response (Emax) of "good drug effect", "bad drug effect", "liking", "stimulated", "high", "anxiety", "I am emotional", "talkative", "happy", "open", "trust", "feeling close to others", "want to be alone", and "want to be with others", assessed by visual analog scale (VAS).
Measured: Every 30 minutes for 9 hours after substance administration
Further acute subjective effects III total effects
Area under the effect curve (AUEC) of "good drug effect", "bad drug effect", "liking", "stimulated", "high", "anxiety", "I am emotional", "talkative", "happy", "open", "trust", "feeling close to others", "want to be alone", and "want to be with others", assessed by visual analog scale (VAS).
Measured: Every 30 minutes for 9 hours after substance administration
Further acute subjective effects IV AMRS
The Adjective Mood Rating Scale (AMRS) assesses the occurrence and intensity of 60 moods on a 4-point Likert scale ranging from "not at all" to "extremely".
Measured: 5 times during each study day: 30 minutes before as well as 2, 4, 6, and 9 hours after substance administration.
Acute autonomic effects I (blood pressure)
Blood pressure (systolic and diastolic) will be measured with an automatic oscillometric device.
Measured: 16 times during each study day: 30 minutes before as well as 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9 hours after substance administration
Acute autonomic effects II (heart rate)
Heart rate will be measured with an automatic oscillometric device.
Measured: 16 times during each study day: 30 minutes before as well as 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9 hours after substance administration
Acute autonomic effects III (body temperature)
Body temperature will be measured with an ear thermometer.
Measured: 16 times during each study day: 30 minutes before as well as 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9 hours after substance administration
Adverse effects (acute and subacute)
The 2011 revised Beschwerden-Liste (B-LR) consists of a 40-item list covering a wide variety of symptoms and complaints that are answered with a four-point intensity-scoring ranging from "not at all" to "strong".
Measured: Before each study day as baseline as well as 9 hours, 3 days and 7 days after substance administration
Subacute effects on general and mental well-being I (WEMWBS)
The Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) is a 14-item questionnaire, that covers different concepts associated with positive mental health, including both hedonic and eudaimonic aspects, positive affect, satisfying interpersonal relationships and positive functioning. For each item an ordinal five-point frequency answer format, ranging from 1 = none of the time" to 5 = "all of the time" is applied.
Measured: Before each study day as baseline as well as 3 days and 7 days after substance administration
Subacute effects on general and mental well-being II (GHQ-12)
The General Health Questionnaire (GHQ-12) consists of a 12-item questionnaire with a four-point response scale assessing general psychological discomfort.
Measured: Before each study day as baseline as well as 3 days and 7 days after substance administration
Subacute effects on general and mental well-being III (SPANE)
The Scale of Positive and Negative Experience (SPANE) is a 12-item questionnaire to capture the affective component of subjective well-being. The SPANE includes six items to assess positive feelings and six items to assess negative feelings. The feelings are reported on a 5-point scale ranging from "very rarely" to "very often or always".
Measured: Before each study day as baseline as well as 3 days and 7 days after substance administration
Subacute effects on subjective sleep quality (ISI)
The Insomnia Severity Index (ISI) is a self-report instrument to assess subjective sleep complaints, screen for insomnia and evaluate treatment response. It consists of seven items scored on a five-point Likert-scale.
Measured: Before each study day as baseline as well as 3 days and 7 days after substance administration
Plasma concentrations of MDMA
Assessed via blood samples. Findings will be described descriptively including maximal concentration (Cmax), time to Cmax, (Tmax) area under the concentration-time curve up to 9 h (AUC0-9) and elimination half-life values.
Measured: 16 times during each study day: 30 minutes before as well as 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9 hours after substance administration
Plasma concentrations of MDMA-metabolites
Assessed via blood samples. Findings will be described descriptively including maximal concentration (Cmax), time to Cmax, (Tmax) area under the concentration-time curve up to 9 h (AUC0-9) and elimination half-life values.
Measured: 16 times during each study day: 30 minutes before as well as 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9 hours after substance administration
Plasma concentrations of Plasma levels of oxytocin
Assessed via blood samples.
Measured: 4 times during each study day: 30 minutes before as well as 2, 4 and 6 hours after substance administration
Effects on life satisfaction, well-being and appreciation before and after study I (BFW/E)
The "Positive Attitude towards Life" is an 8-item subscale of the 39-item Bern Subjective Well-Being Questionnaire for Adolescents (BFW/E). The BFW enables a reliable and valid assessment of different dimensions of subjective well-being in adolescents and adults. Changes over the course of the study are assessed.
Measured: Twice during study: at screening and at end of study 12-14 weeks later.
Effects on life satisfaction, well-being and appreciation before and after study II (GLS)
Global life satisfaction is assessed based on a single item life satisfaction measure. The question can be answered on a 11-point scale: "In general, how satisfied are you with your life if 0 means 'not at all satisfied' and 10 means 'completely satisfied'?". Changes over the course of the study are assessed.
Measured: Twice during study: at screening and at end of study 12-14 weeks later.
Effect moderation by personality traits I (NEO-FFI)
Personality traits are known to affect subjective responses to psychoactive substances and are assessed for explorative future analysis of pooled data. The NEO Five Factor Inventory (NEO-FFI) is a self-description questionnaire with 60 items for the measurement of the "big five": neuroticism, extraversion, openness, agreeableness, and consciousness. It uses a 5-point Likert scale ranging from "completely disagree" to "fully agree".
Measured: Baseline
Effect moderation by personality traits II (FPI-R)
Personality traits are known to affect subjective responses to psychoactive substances and are assessed for explorative future analysis of pooled data. The Freiburger Personality Inventory (FPI-R) version comprises 138 items and covers 12 dimensions of personality: life satisfaction, social orientation, performance orientation, inhibition, excitability, aggressiveness, stress, physical complaints, health concerns, openness, as well as the secondary factors according to Eysenck's Extraversion and Emotionality (Neuroticism). It uses a 2-point scale ("true" and "not true").
Measured: Baseline
Effect moderation by personality traits III (SPF)
Personality traits are known to affect subjective responses to psychoactive substances and are assessed for explorative future analysis of pooled data. The Saarbrücker Persönlichkeitsfragebogen (SPF) defines empathy as the "reactions of one individual to the observed experiences of another." It assesses 28-items on a 5-point Likert scale ranging from "Does not describe me well" to "Describes me very well". The measure has 4 subscales (Perspective Taking, Fantasy, Empathic Concern, Personal Distress) each made up of 7 different items.
Measured: Baseline
Effect moderation by personality traits IV (HEXACO)
Personality traits are known to affect subjective responses to psychoactive substances and are assessed for explorative future analysis of pooled data. The HEXACO personality inventory is a six-dimensional model of human personality with 100 items.The six factors are: Honesty-Humility, Emotionality, Extraversion, Agreeableness, Conscientiousness and Openness to Experience.
Measured: Baseline
Effect moderation by personality traits V (DSQ-40)
Personality traits are known to affect subjective responses to psychoactive substances and are assessed for explorative future analysis of pooled data. The Defense Style Questionnaire (DSQ-40) can provide scores for 20 individual defenses, and scores for the three factors "mature", "neurotic", and "immature". Each item is evaluated on a scale from 1 to 9, where "1" indicates "completely disagree" and "9" indicates "fully agree".
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start17 Nov 2023
- Primary completion7 Mar 2025
- Study completion7 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 3-period, random order, placebo-controlled, double-blind cross-over study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias E Liechti, Prof. Dr. MD, Principal investigator, University Hospital Basel, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809271
- Sponsor's protocol ID
- BASEC 2023-00167
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2023
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of 3,4-methylenedioxymethamphetamine (MDMA) With and Without a Booster Dose (MDMA-booster Study)
- ClinicalTrials.gov ID
- NCT05809271
- Acronym / sponsor ID
- BASEC 2023-00167
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 7 Mar 2025 (actual)
- Study completion
- 7 Mar 2025 (actual)
- First posted
- 12 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
3,4-methylenedioxymethamphetamine (MDMA) is a psychoactive substance and prototypical empathogen acutely inducing feelings of heightened mood, empathy, trust and closeness to others. The current study investigates differences in duration of acute effects and side effects after administration of a single dose of MDMA compared to a repeated administration.
Detailed description
MDMA is a psychoactive substance that primarily enhances serotonergic neurotransmission by releasing 5-HT through the SERT. It also releases dopamine and norepinephrine, although less potently, through the dopamine transporter and norepinephrine transporter, respectively. In addition to its use as a recreational drug, MDMA-assisted psychotherapy has been investigated in several phase 2 trials and one phase 3 trial for PTSD. Further indications for MDMA-assisted therapy being planned or ongoing are eating disorders, social anxiety, and alcohol use disorder.
The present study focuses on dosing aspects of MDMA used in clinical studies and recreational settings, specifically the benefits of a second administration (booster dose) given several hours after the initial dose. Most published studies of MDMA-assisted psychotherapy used a booster dose. A typical dosing regimen would be 80-120 mg of MDMA initially followed by half the initial dose after 1.5-2.5 hours. Although previous studies have found that a booster dose could prolong the acute effects of MDMA, others have shown an acute tolerance reflected in the finding that acute subjective effects return to baseline within 4-5 hours, while plasma concentrations are still close to peak levels.
These findings have led to controversy regarding how effective a booster dose would be in prolonging acute effects, as it has never been directly compared to placebo. Additionally, the higher total dose could lead to an increase in side effects.
Therefore, the present phase 1 study intends to compare the acute subjective, physiological, and endocrine effects of MDMA (120 mg + 60 mg after 2 hours), MDMA (120 mg + placebo after 2 hours), and (placebo + placebo after 2 hours) using a double-blind, random-order, crossover design in healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- 3-period, random order, placebo-controlled, double-blind cross-over study
| Arm | Type | Receives |
|---|---|---|
| MDMA with booster | Experimental | Drug: MDMA 120 mg + MDMA 60 mgMDMA followed by MDMA |
| MDMA without booster | Experimental | Drug: MDMA 120 mg + placeboMDMA followed by placebo |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo followed by placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Good understanding of the German language.
- Understanding the procedures and the risks that are associated with the study.
- Participants must be willing to adhere to the protocol and sign the consent form.
- Participants must be willing to refrain from taking illicit psychoactive substances during the study.
- Participants must be willing to drink only alcohol-free liquids and no coffee, black or green tea, or energy drinks after midnight of the evening before the study session, as well as during the study day.
Key exclusion criteria (10 listed)
- Relevant chronic or acute medical condition.
- Current or previous major psychiatric disorder.
- Psychotic disorder in first-degree relatives, not including psychotic disorders secondary to an apparent medical reason, e.g. brain injury, dementia, or lesions of the brain.
- Hypertension (SBP>140/90 mmHg) or hypotension (SBP<85 mmHg).
- Previous MDMA use more than 20 times or any time within the previous month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MDMA 120 mg + MDMA 60 mgAlso: 3,4-MethylenedioxymethamphetamineAn oral dose of 120 mg racemic MDMA will be administered followed by a second dose of 60 mg racemic MDMA two hours later. | Drug | MDMA with booster |
| MDMA 120 mg + placeboAlso: 3,4-MethylenedioxymethamphetamineAn oral dose of 120 mg racemic MDMA will be administered followed by a placebo two hours later. | Drug | MDMA without booster |
| PlaceboAn oral placebo will be administered followed by a placebo two hours later. | Drug | Placebo |
Primary outcome
Subjective effect duration for "any drug effect"
Time frame: Every 15 minutes for 9 hours after substance administration
Assessed by visual analog scale (VAS) using 10% of the individual maximal subjective response (Emax) as threshold for the onset and offset.
24 secondary outcomes
Maximal subjective effects for "any drug effect"
Time frame: Every 15 minutes for 9 hours after substance administration
Total subjective effects for "any drug effect"
Time frame: Every 15 minutes for 9 hours after substance administration
Further acute subjective effects I duration
Time frame: Every 30 minutes for 9 hours after substance administration
Further acute subjective effects II maximal effects
Time frame: Every 30 minutes for 9 hours after substance administration
Further acute subjective effects III total effects
Time frame: Every 30 minutes for 9 hours after substance administration
Further acute subjective effects IV AMRS
Time frame: 5 times during each study day: 30 minutes before as well as 2, 4, 6, and 9 hours after substance administration.
Acute autonomic effects I (blood pressure)
Time frame: 16 times during each study day: 30 minutes before as well as 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9 hours after substance administration
Acute autonomic effects II (heart rate)
Time frame: 16 times during each study day: 30 minutes before as well as 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9 hours after substance administration
Acute autonomic effects III (body temperature)
Time frame: 16 times during each study day: 30 minutes before as well as 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9 hours after substance administration
Adverse effects (acute and subacute)
Time frame: Before each study day as baseline as well as 9 hours, 3 days and 7 days after substance administration
Subacute effects on general and mental well-being I (WEMWBS)
Time frame: Before each study day as baseline as well as 3 days and 7 days after substance administration
Subacute effects on general and mental well-being II (GHQ-12)
Time frame: Before each study day as baseline as well as 3 days and 7 days after substance administration
Subacute effects on general and mental well-being III (SPANE)
Time frame: Before each study day as baseline as well as 3 days and 7 days after substance administration
Subacute effects on subjective sleep quality (ISI)
Time frame: Before each study day as baseline as well as 3 days and 7 days after substance administration
Plasma concentrations of MDMA
Time frame: 16 times during each study day: 30 minutes before as well as 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9 hours after substance administration
Plasma concentrations of MDMA-metabolites
Time frame: 16 times during each study day: 30 minutes before as well as 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9 hours after substance administration
Plasma concentrations of Plasma levels of oxytocin
Time frame: 4 times during each study day: 30 minutes before as well as 2, 4 and 6 hours after substance administration
Effects on life satisfaction, well-being and appreciation before and after study I (BFW/E)
Time frame: Twice during study: at screening and at end of study 12-14 weeks later.
Effects on life satisfaction, well-being and appreciation before and after study II (GLS)
Time frame: Twice during study: at screening and at end of study 12-14 weeks later.
Effect moderation by personality traits I (NEO-FFI)
Time frame: Baseline
Effect moderation by personality traits II (FPI-R)
Time frame: Baseline
Effect moderation by personality traits III (SPF)
Time frame: Baseline
Effect moderation by personality traits IV (HEXACO)
Time frame: Baseline
Effect moderation by personality traits V (DSQ-40)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias E Liechti, Prof. Dr. MD principal investigator
University Hospital Basel, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MDMA 120 mg + MDMA 60 mg in people with Healthy, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective effect duration for "any drug effect" (time frame: Every 15 minutes for 9 hours after substance administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.